FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057625 [Registered on: 14/09/2023] Trial Registered Prospectively
Last Modified On: 27/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   comparison of hemodynamic parameters during pneumoperitoneum,post operative pain control in three groups placebo group, lignocaine group ,dexmedetomidine group 
Scientific Title of Study   To compare the attenuation of hemodynamic response to pneumoperitoneum during laparoscopic cholecystectomy between lignocaine and dexmedetomidine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Megha Manoj 
Designation  Pg student Anaesthesia  
Affiliation  Vydehi institute of medical sciences and research centre 
Address  Vydehi institute of medical sciences and research centre,Anaesthesia department, Bangalore, Karnataka

Bangalore
KARNATAKA
560066
India 
Phone  8590190660  
Fax    
Email  meghamanoj97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Radhika Dhanpal 
Designation  Hod and Professor , Department of Anaesthesia 
Affiliation  Vydehi institute of medical sciences and research centre 
Address  Vydehi institute of medical sciences and research centre,Anaesthesia department Bangalore, Karnataka

Bangalore
KARNATAKA
560066
India 
Phone  8049069000  
Fax    
Email  radhika5276@vimsmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Radhika Dhanpal 
Designation  Hod and Professor , Department of Anaesthesia 
Affiliation  Vydehi institute of medical sciences and research centre 
Address  Vydehi institute of medical sciences and research centre,Anaesthesia department Bangalore, Karnataka

Bangalore
KARNATAKA
560066
India 
Phone  8049069000  
Fax    
Email  radhika5276@vimsmail.com  
 
Source of Monetary or Material Support  
Vydehi institute of medical sciences and research centre, Bangalore , Karnataka 
 
Primary Sponsor  
Name  Vydehi institute of medical sciences and research centre 
Address  Vydehi institute of medical sciences and research centre, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Vijayanagar, Nallurhalli, Bengaluru, Karnataka 560066 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Megha Manoj  Vydehi Institute Of Medical Sciences And Research Centre  Anaesthesia department, 1st floor,Operation Theatre complex
Bangalore
KARNATAKA 		 8590190660

meghamanoj97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VYDEHI INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LIGNOCAINE ,DEXMEDETOMIDINE  comparison of hemodynamic parameters during pneumoperitoneum,post operative pain control in three groups placebo group, lignocaine group ,dexmedetomidine group 
Comparator Agent  LIGNOCAINE,DEXMEDETOMIDINE  comparison of hemodynamic parameters during pneumoperitoneum,post operative pain control in three groups placebo group, lignocaine group ,dexmedetomidine group,dexmedetomidine group  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)ASA 1-2
2)PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY 
 
ExclusionCriteria 
Details  1)PATIENT REFUSAL
2)ALLERGY TO LOCAL ANAESTHETIC AGENTS
3)PREGNANT AND LACTATING WOMEN 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to assess the efficacy of lignocaine & dexmedetomidine in altering hemodynamic response during pneumoperitoneum  before induction , before pneumoperitoneum, every 5 minutes during pneumoperitoneum for 30 minutes then half hourly till deflation,after extubation ,in recovery room
postop 4 hrs,8 hrs,12 hrs, 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
comparing the time of request for first postoperative analgesia, sedation  ramsay sedation score immediate post op
vas score every 4 hours for 24 hours
request for first postoperative analgesia 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [meghamanoj97@gmail.com].

  6. For how long will this data be available start date provided 06-03-2025 and end date provided 11-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Laryngoscopy ,endotracheal intubation, pneumoperitoneum, and extubation do lead to significant pressor response in patients undergoing laparoscopic cholecystectomy. Our study is aimed at observing the attenuation of these sympathoadrenal responses using dexmedetomidine and lignocaine hence providing intraoperative hemodynamic stability, better post operative pain control , minimal opioid consumption and it’s side effects, decreased duration of stay in hospital  
Close